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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dislodger, Stone, Biliary
510(k) Number K203322
Device Name SpyGlass Discover Retrieval Basket
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough,  MA  01749
Applicant Contact Lindsay Forys
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough,  MA  01749
Correspondent Contact Lindsay Forys
Regulation Number876.5010
Classification Product Code
LQR  
Date Received11/12/2020
Decision Date 05/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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